BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2305792 · Received October 24, 2011

    Report

    Report Number
    2050012-2011-06534
    Event Type
    Malfunction
    Date Received
    October 24, 2011
    Date of Event
    September 25, 2011
    Report Date
    September 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE INSTRUMENT ISSUE COULD NOT BE DETERMINED; HOWEVER, THE REPAIRS AND ADJUSTMENTS EFFECTIVELY RESOLVED THE ISSUE. (NOTE: THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).)

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE UNICEL DXC 800 SYNCHRON SYSTEM GENERATED FALSELY HIGH MAGNESIUM (MG) RESULTS AND ERRATIC GLUCOSE (GLU) RESULTS. CUSTOMER REPORTED THAT A TECHNICIAN RAN THREE MAGNESIUM PATIENTS SAMPLES, ALL OF WHICH YIELDED RESULTS OF 6.0 MILLIGRAMS PER DECILITER (MG/DL). THE TECHNICIAN REPEATED THE PATIENT SAMPLES ON ANOTHER INSTRUMENT AND RECEIVED RESULTS OF 2.0 MG/DL, 2.0 MG/DL, AND 1.9 MG/DL. ALSO, THE INSTRUMENT GENERATED A CRITICALLY LOW GLUCOSE RESULT OF 39 MG/DL, FOLLOWED BY A REPEATED RESULT OF 53 MG/DL; THE OTHER INSTRUMENT GENERATED A RESULT OF 40 GM/DL. ON THE FOLLOWING DAY, THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THAT THE SAMPLE MIXER WASH STATION WAS OBSTRUCTED, CAUSING THE SAMPLE MIXER TO STAY UNWASHED. THE REAGENT MIXER WASH STATION WAS PARTIALLY OBSTRUCTED, PRODUCING ONE WASHING STREAM. THE FSE REMOVED AND THEN CLEANED THE MIXER WASH STATION INSERTS. THE FSE THEN VERIFIED THAT THE MIXER WASH STATIONS WERE FUNCTIONING PROPERLY. THE FSE ALSO RE-ALIGNED THE SAMPLE MIXER PADDLE, THE WASH COLLAR, AND THE PROBE ROTARY. LASTLY, THE FSE REPLACED THE SAMPLE PROBE. CUSTOMER DID NOT PROVIDE SPECIFIC PATIENT INFORMATION. CUSTOMER STATED THAT NO ERRONEOUS PATIENT RESULTS WERE REPORTED OUTSIDE THE LABORATORY; THEREFORE, PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1